Observational, Non-interventional, Non Comparative Real Life Data Collection of Depo-Eligard® 7.5 mg, 22.5 mg and 45 mg in Male Prostate Cancer Patients

Prostate Cancer Clinical Trial

— TREMODI  

Official title:

Phase IV, Non-interventional, Prospective, Open Label, Non Comparative Real Life Data Collection of Depo-Eligard® 7.5 mg, 22.5 mg and 45 mg in Male Prostate Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01793077
• Other study ID #: BE-11-EGD-04
• Status: Completed
• Phase: N/A
• First received: February 13, 2013
• Last updated: January 10, 2014
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Tremodi is an observational, non-interventional, prospective, open-label, non-comparative study that will collect real life data of a treatment with Depo-Eligard® in 3 different administrations in male prostate cancer patients.

Once the examining physician has decided on the therapeutic approach and if the selection criteria are fulfilled, he will propose the patient to participate in the study. An informed consent form will be collected for all participants in the study.

There are 2 possible study visits that coincide with a routine consultation, namely visit 1 (inclusion visit) and visit 2 (end of study visit). On both visits, Adverse Drug Reactions (adverse event caused by Depo-Eligard®) are collected and the patient will be asked to complete a Quality Of Life questionnaire (EORTC QLQ-C30). At visit 2, the examining physician will give a global evaluation of the treatment with Depo-Eligard® and assesses the treatment benefit of the patient.

Testosterone and Prostate Specific Antigen (PSA) blood values are collected during both visits, if available.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients having been prescribed Depo-Eligard® 7.5 mg - 22.5 mg - 45 mg in accordance with the terms of the marketing authorization.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Depo-Eligard®
Subcutaneous

Locations

Country	Name	City	State
Belgium	Site: 32	Aalst	East Flanders
Belgium	Site: 14	Antwerpen	Antwerp
Belgium	Site: 4	Antwerpen	Antwerp
Belgium	Site: 5	Antwerpen	Antwerp
Belgium	Site: 8	Antwerpen	Antwerp
Belgium	Site: 9	Antwerpen	Antwerp
Belgium	Site: 13	Brussel	Brussels Capital Region
Belgium	Site: 23	Bruxelles	Brussels Capital Region
Belgium	Site: 34	Dendermonde	East Flanders
Belgium	Site: 11	Gent	East Flanders
Belgium	Site: 21	Ieper	West Flanders
Belgium	Site: 20	Izegem	West Flanders
Belgium	Site: 25	Kortijk	West Flanders
Belgium	Site: 39	La Louvière	Hainaut
Belgium	Site: 26	Lasne Chapelle Saint Lambert	Walloon Brabant
Belgium	Site: 38	Liège
Belgium	Site: 33	Merksem	Antwerp
Belgium	Site: 31	Oostende	West Flanders
Belgium	Site: 17	Oudenaarde	East Flanders
Belgium	Site: 37	Sint Truiden	Limburg
Belgium	Site: 18	Tienen	Flemish Brabant
Belgium	Site: 1	Turnhout	Antwerp
Belgium	Site: 24	Uccle	Brussels Capital Region

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Europe B.V.	Veeda Clinical Research

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of tolerability of treatment on a 4 point scale		Last Visit (after at least 180 days of treatment)	No
Secondary	Occurrence of Adverse Drug Reactions		Day 1 and Last Visit (after at least 180 days of treatment)	No
Secondary	Investigator satisfaction with treatment		Last Visit (after at least 180 days of treatment)	No
Secondary	Overall patient's assessment of treatment benefit		Last Visit (after at least 180 days of treatment)	No
Secondary	Changes in quality of life of subjects as measured by EORTC QLQ-C30	European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-C 30 (EORTC-QLQ-C30)	Day 1 and Last Visit (after at least 180 days of treatment)	No
Secondary	Frequency of use of dosing schedules of Depo-Eligard® and the reasons for selecting a schedule		Day 1 and Last Visit (after at least 180 days of treatment)	No
Secondary	Efficacy of treatment	(1) Changes in PSA and testosterone levels if available, (2) Change in disease symptoms and (3) Objective disease response	Day 1 and Last Visit (after at least 180 days of treatment)	No